Elevation of the Fetal Buttocks Prior to External Cephalic Version

Overseen By David A Hill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Multiple fetuses, Uterine incision, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a balloon device called the Fetal Pillow, which helps lift a breech baby's bottom to make it easier to turn them head-first. It targets first-time pregnant women in the later stages of pregnancy with breech babies. The balloon is inflated inside the vagina to assist in turning the baby.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Fetal Pillow treatment differ from other treatments for cesarean delivery at full cervical dilatation?

The Fetal Pillow is a unique device used during cesarean delivery to elevate the baby's head when it is deeply impacted in the pelvis, which can reduce birth trauma for both the mother and baby. This differs from other methods, like the hand-push technique, by potentially lowering the risk of complications such as uterine incision extension and reducing the need for additional interventions. ^{1 2 3 4 5}

Research Team

Ariana Mora

Principal Investigator

AdventHealth

David A Hill, MD

Principal Investigator

AdventHealth

Eligibility Criteria

Inclusion Criteria

Patient speaks English or Spanish as primary language.

Patient able to understand verbal and written consent

Women delivering at AdventHealth Orlando campus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo the external cephalic version (ECV) procedure with either inflation or sham inflation of the Fetal Pillow device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ECV procedure, including fetal monitoring and assessment for complications

up to 72 hours

In-hospital monitoring

Post-procedure monitoring

Monitoring for delivery outcomes and costs for the mother and neonate

up to 42 days

Treatment Details

Interventions

• Fetal Pillow insertion

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Inflation of the balloon device

Group II: Control Placebo Group 1 Intervention

Non-inflation of the balloon device

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the fetal pillow to prevent adverse maternal and fetal outcomes at full dilatation cesarean section in routine practice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of maternal and neonatal outcomes from full-dilatation cesarean deliveries using the Fetal Pillow or hand-push method. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of outcomes at full-dilation cesarean section with and without the use of a fetal pillow device. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Maternal and neonatal outcomes following the introduction of the Fetal Pillow at a tertiary maternity hospital: A retrospective cohort study. [2023]